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FDA 510(k)

RIWOLITH 2280

K-Number: K913487 · 1992-02-05

ApplicantRichard Wolf Medical Instruments Corp.
Decision Date1992-02-05
Product CodeFFK
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

RIWOLITH 2280 is the device name listed in this FDA 510(k) record. The listed applicant is Richard Wolf Medical Instruments Corp.. It received FDA 510(k) clearance on 1992-02-05 under 510(k) number K913487. The device is classified under product code FFK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RIWOLITH 2280?

RIWOLITH 2280 is a medical device that received FDA 510(k) clearance on 1992-02-05. The listed applicant is Richard Wolf Medical Instruments Corp.. The 510(k) number is K913487.

When did RIWOLITH 2280 receive FDA 510(k) clearance?

RIWOLITH 2280 received FDA 510(k) clearance on 1992-02-05, under 510(k) number K913487.

Who is the listed applicant for RIWOLITH 2280?

The FDA 510(k) record lists Richard Wolf Medical Instruments Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RIWOLITH 2280?

The FDA product code for RIWOLITH 2280 is FFK.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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